Big Pharma companies have often talked about the major opportunities that await in China. But as price cuts play out and internal priorities shift, multinational companies are reworking their business models in the country. In the last few months of 2023, Pfizer, GSK, Sanofi and Biogen have each tapped local partners to help commercialize their products in China. With marketing responsibilities shifting to other firms, job cuts were expected at each of those large drugmakers. It’s not a new approach for foreign drugmakers to tap local partners in China, Justin Wang, head of L.E.K. Consulting’s China practice, pointed out in an email interview with Fierce Pharma. But these deals are on the rise lately, Wang explained, partly because “there is increasing pricing and competitive pressure in the market, especially for mature products, leaving reduced [return on investment] for in-house commercial resources.” Pfizer in November unveiled a deal with Keyuan Pharma, ...
AstraZeneca is acquiring Icosavax, which has technology well-suited for multivalent vaccines. Icosavax’s pipeline includes a Phase 3-ready program that protects against two pathogens that cause severe respiratory infections in older adults. By FRANK VINLUAN AstraZeneca is already in the respiratory syncytial virus market with two products, including the drug Beyfortus, approved earlier this year. An M&A deal will give AstraZeneca an RSV vaccine candidate based on technology that could help the company compete where new vaccines are going. AstraZeneca is acquiring clinical-stage Icosavax for $800 million up front, the pharmaceutical giant announced Tuesday. Under the deal terms, AstraZeneca will pay $15 for each Icosavax share, which is a nearly 43% premium to the stock’s closing price on Monday. AstraZeneca could pay an additional $5 per share depending on the progress of Icosavax’s vaccine candidates. That payout could bring the value of the deal to $1.1 billion. The vaccines of Seattle-based ...
After multiple expansion forays overseas this year, biomanufacturing outfit National Resilience is returning to its American roots with plans to beef up production and add hundreds of new jobs at a recently purchased plant in Ohio. Resilience is expanding operations at the West Chester, Ohio, facility it bought from AstraZeneca in January, the technology-focused contract manufacturer said Monday. In turn, the company expects to create some 440 new jobs with an associated annual payroll of nearly $29 million over the next three years. The project represents a partnership between Resilience, JobsOhio and Cincinnati’s Regional Economic Development Initiative (REDI), the company noted. All told, the plan is set to nearly double Resilience’s current presence in West Chester, according to JobsOhio president and CEO J.P. Nauseef. In the company’s press release, Resilience’s CEO Rahul Singhvi pointed out that the West Chester site serves as the CDMO’s global center of excellence for commercial ...
Pfizer already reported its experimental drug for hemophilia A and B met a pivotal study’s goals of reducing bleeding episodes. During the annual meeting of the American Society of Hematology, the company presented a full look at the results, which are expected to support regulatory submissions soon. By FRANK VINLUAN Patients with hemophilia A or B can manage the inherited bleeding disorders with regular infusions of the clotting proteins they lack. This treatment helps—until it doesn’t. One problem with these infused factor replacement therapies is patients can develop inhibitors, which are antibodies that render the clotting proteins ineffective. Experimental Pfizer drug marstacimab takes a different approach to both forms of hemophilia. Results from a pivotal study show the subcutaneously injected drug met the main goals of reducing bleeding episodes. The company also has some additional long-term data showing continuing improvement beyond the initial clinical trial evaluation period. The full Phase ...
IGM Biosciences plans to axe 22% of its workforce, becoming the latest company to downsize in a bid to free cash resources. Amid the layoffs, the US-based biotechnology company will also reprioritise its pipeline, discontinuing operations for all haematologic oncology and targeted cytokine product development while doubling down on its efforts in the clinical development of T cell engagers for autoimmune diseases and a DR5 agonist for colorectal cancer. IGM expects the restructuring to extend the company’s cash runway into Q2 2026. The restructuring comes less than a month after the company said it anticipated an increase in headcount to support the research and development of its pipeline candidates, citing its intent to advance and expand its antibody product pipeline, in its 13 November 10-Q filing. In the same filing, the company acknowledged that it had significant net losses to date and that achieving profitability sufficient enough to offset the ...
By Tristan Manalac Pictured: GSK building in Poznan, Poland/iStock, Wirestock GSK CEO Emma Walmsley on Thursday touted the smooth launch of its respiratory syncytial virus vaccine Arexvy and its strong potential for growth in the coming years. In an interview with Reuters, Walmsley said the British biopharma is “delighted” with the progress it has made in the RSV vaccine race with Pfizer. “We are delighted with the start of our RSV vaccine,” Walmsley said, adding that the company expects Arexvy “will be more than £1 billion in its first year, (it) has lots of headroom for growth.” GSK is positioning Arexvy to be its next blockbuster asset. The U.S. launch of the vaccine has so far reached three million of the more than 80 million adults over 60 at risk from RSV, according to Walmsley. Arexvy became the first FDA-approved RSV shot in May 2023 and is authorized for use ...
As gene therapies ramp up in spinal muscular atrophy and hemophilia, it may soon be the turn of Gaucher disease patients to realize the latent potential of this type of treatment. That’s according to analysts at GlobalData, which spoke to key opinion leaders (KOLs) during the recent International Gaucher Disease Awareness Month to gauge their thoughts of gene therapy in this space. GlobalData said in an accompanying report that these KOLs believe pipeline gene therapies “will significantly impact the Gaucher disease landscape,” given that it has the curative potential to provide patients with a healthy GBA1 copy, disrupting the Gaucher drug market. However, much “groundwork remains to be covered,” the analysts cautioned. Gaucher disease is a rare inherited metabolic disorder caused by defects in the GBA1 gene and comes with three distinct types of the disease with varying severity. The rare condition is typically characterized by the accumulation of fatty ...
Don Tracy, Associate Editor Trial results expected to accelerate the potential of Dupixent to become the first FDA-approved treatment for chronic obstructive pulmonary disease. Regeneron Pharmaceuticals and Sanofi have announced that a Phase 3 trial evaluating Dupixent (dupilumab) in the treatment of chronic obstructive pulmonary disease (COPD) showed the drug reduced exacerbations by 34%, reportedly confirming positive results from its earlier Phase 3 BOREAS trial. According to a Regeneron press release, the NOTUS trial also confirmed that treatment led to rapid and significant improvements in lung function by 12 weeks and were sustained at 52 weeks. Back in May, the companies also announced the success of the aforementioned BOREAS trial for investigational use of Dupixent in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with COPD and evidence of type 2 inflammation. Earlier this year, the drug was granted FDA Breakthrough Therapy designation as an add-on maintenance treatment in ...
Simcere has entered a licensing agreement with Connect Biopharma for the development of a monoclonal antibody (MAb) candidate rademikibart (CBP-201) against allergic inflammation in autoimmune conditions such as atopic dermatitis (AD) and asthma. Under the deal, the Nanjing, China-headquartered company will have a licence for the development and commercialisation of rademikibart in mainland China, Macau, Taiwan, and Hong Kong. Connect retains its rights to the MAb outside Greater China. Rademikibart is a humanIgG4 MAb that binds to IL-4Rα, which can be administered as a subcutaneous or intravenous (IV) injection. Sanofi and Regeneron Pharmaceuticals’ Dupixent (dupilumab) has dominated the AD drug market since it first gained a US Food and Drug Administration (FDA) approval in March 2017. Dupixent had generated $6.4bn in US sales up until 30 September, according to Regeneron’s Q3 2023 report. It is forecast to make over $11bn in global sales for all indications by the end of ...
By Tristan Manalac The European Patent Office has decided that a hotly contested mRNA patent held by Moderna pertaining to its COVID-19 vaccine is invalid, Reuters reported on Tuesday. The patent in question covers betacoronavirus vaccines that use at least one RNA polynucleotide with an open reading frame that encodes at least one betacoronavirus antigenic peptide, according to its claims document listed in the European Patent Register. While the patent battle is over the use of this technology to produce COVID-19 vaccines, the claims document also seeks to protect its use for other viral respiratory infections, including MERS and SARS. Several biopharma companies have lodged their opposition to these claims, including BioNTech and Pfizer—Moderna’s chief competitors in the coronavirus vaccine market—as well as Sanofi, according to the patent’s listing on the register. A BioNTech spokesperson in a statement to Fierce Pharma said that the company “welcomes” the European Patent Office’s ...
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